Sitagliptin In Elderly Patients Research Articles

Comparison of Visceral Fat Reduction by Ipragliflozin and Metformin in Elderly Type 2 Diabetes Patients: Sub-Analysis of a Randomized-Controlled Study.

IntroductionTo compare the effects of ipragliflozin, a sodium-glucose transporter 2 inhibitor, with those of metformin on visceral fat (as well as muscles and bones) in Japanese elderly patients with type 2 diabetes (T2D), we conducted a sub-analysis of a prospective, multicenter, blinded-endpoint randomized-controlled study.MethodsIn total, 103 patients with T2D (body mass index ≥ 22 kg/m2; glycated hemoglobin, 7–10%) and being treated with sitagliptin (a dipeptidyl peptidase-4 inhibitor) were included and randomized to receive ipragliflozin or metformin. The primary outcome was the change in visceral fat area measured using computed tomography 24 weeks following treatment. The secondary outcomes included changes in subcutaneous and total fat area, muscle volume, bone density measured using computed tomography, handgrip strength, bone markers, plasma glucose, insulin, homeostasis model assessment (HOMA)2-beta, HOMA2-R, glycated hemoglobin, lipid panel, uric acid, blood pressure, adiponectin, and high-sensitivity C-reactive protein. All patients aged 65–74 years were selected for sub-analysis.ResultsThe sub-analysis included 15 and 14 patients in the ipragliflozin and metformin groups, respectively. The patients’ backgrounds were well balanced. Visceral fat area reduction was greater in the ipragliflozin group than in the metformin group (− 10.58% vs. − 6.93%; P = 0.034). There were significant differences in the changes in bone absorption markers, uric acid, and total cholesterol levels between the groups.ConclusionIpragliflozin significantly reduced the visceral fat area compared with metformin when added to sitagliptin in elderly patients with T2D. Long-term and large-scale studies are required to elucidate whether ipragliflozin is suitable for elderly patients.Trial RegistrationThe study was registered at https://www.umin.ac.jp/ctr/ (UMIN-ID: UMIN 000015170).Electronic supplementary materialThe online version of this article (10.1007/s13300-020-00949-0) contains supplementary material, which is available to authorized users.

Type 2 diabetes mellitus in elderly patients treated with endocrinologists in clinical practice

A large-scale epidemic of type 2 diabetes mellitus (T2DM) is observed with advanced ageing worldwide. The prevalence of T2DM significantly increases with age. Therefore, this review aimed to summarise the data on T2DM in advanced and older aged patients. The primary geriatric syndromes, which should be considered for the management of older patients (cognitive impairment, sarcopenia, orthostatic hypotension, falls, urinary incontinence, senile asthenia, etc.), are presented. The causes of the high risk for hypoglycaemia in elderly patients are analysed. Improving the treatment for T2DM is a priority of modern medicine. Using antihyperglycaemic therapy is especially difficult in this population due to the high risk of hypoglycaemia and the multi-organ pathology leading to polypharmacy. Therefore, special attention is paid to treatment recommendations. Hypoglycaemic drugs used in elderly patients should be low risk of hypoglycaemia, without nephro- and hepatic toxicity, safe for cardiovascular organs, easy to administer. Furthermore, advantages and limitations of using various groups of hypoglycaemic drugs in elderly patients are discussed. DPP-4 inhibitors are also considered in detail. Modern data on mechanisms of hypoglycaemic action of DPP-4 inhibitors are presented. Possibilities of using sitagliptin in elderly patients were also considered. Finally, evidence-based studies demonstrating the obvious advantages of sitagliptin for the treatment of T2DM in the elderly and advanced aged population are discussed.

Efficacy and Safety of Adding Sitagliptin in Type 2 Diabetes Patients on Insulin: Age-Stratified Comparison at One Year in the ASSIST-K Study.

BackgroundSitagliptin, the first dipeptidyl peptidase-4 inhibitor, has demonstrated efficacy and safety as monotherapy and as add-on therapy to oral antidiabetic agents or insulin. However, there have been few reports about sitagliptin in elderly patients. The ASSIST-K observational study was performed in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin as add-on therapy to insulin. Changes of hemoglobin A1c (HbA1c), body weight, and the estimated glomerular filtration rate (eGFR), as well as adverse events, were investigated over 12 months in age-stratified groups.MethodsAmong outpatients with T2DM treated at member institutions of Kanagawa Physicians Association, those starting sitagliptin as add-on therapy to insulin were followed for 12 months. HbA1c (National Glycohemoglobin Standardization Program), body weight, and eGFR were the efficacy endpoints, while adverse events were investigated to assess safety. Patients were stratified into three age groups (≤ 64 years, 65 - 74 years, and ≥ 75 years) for comparison of the endpoints.ResultsAmong 937 patients on insulin before starting sitagliptin, 821 patients were analyzed after excluding those without HbA1c data at baseline and 12 months. The two groups of elderly patients (65 - 74 years and ≥75 years) had more complications and their HbA1c was lower at initiation of sitagliptin therapy. The dose of sitagliptin, daily number of insulin injections, and number of concomitant oral antidiabetic agents were all lower in the elderly patients. HbA1c showed a significant decrease after initiation of sitagliptin in all age groups, and there were no significant intergroup differences in the change of HbA1c at 12 months. Body weight did not change significantly in any group. eGFR decreased significantly in all groups, with no significant intergroup differences at 12 months. Regarding adverse events, there were no significant intergroup differences in the incidence of severe hypoglycemia, gastrointestinal symptoms, or constipation.ConclusionsDespite baseline differences in demographic factors and medications, sitagliptin showed good efficacy and safety in all age groups of patients receiving it as add-on therapy to insulin during routine management of T2DM. Adding sitagliptin to insulin achieves similar efficacy and safety outcomes at 12 months in both elderly and non-elderly T2DM patients.

Efficacy and safety of sitagliptin in elderly patients with type 2 diabetes mellitus: A focus on hypoglycemia.

Aims/IntroductionTo investigate the efficacy and safety of sitagliptin in elderly patients with type 2 diabetes mellitus, with a focus on hypoglycemia.Materials and MethodsType 2 diabetes mellitus patients who started sitagliptin therapy and were followed for 52 weeks were enrolled in the Impact of Sitagliptin on Diabetes Mellitus in Japanese Elderly Patients study. The frequency of hypoglycemia and knowledge of hypoglycemia were analyzed using a questionnaire.ResultsIn total, 5,130 patients (aged 73.8 ± 6.1 years) were analyzed. A significant reduction in glycated hemoglobin (−0.7 ± 1.1%, P < 0.001) and glycoalbumin levels (−2.2 ± 3.8%, P < 0.001) was observed at week 52. The percentage of patients with hypoglycemia did not increase from the baseline (3.3%) to week 52 (2.8%) of sitagliptin administration. Hypoglycemia incidence was significantly higher for combination therapy with insulin (odds ratio 17.75, P < 0.001) or sulfonylurea (odds ratio 2.22, P < 0.001). The increase in sitagliptin dose for combination therapy with antidiabetic drug(s) increased the percentage of patients with hypoglycemia (5.6% in sitagliptin increased subgroup, 2.4% in sitagliptin maintained subgroup, P < 0.01). The awareness of hypoglycemia symptoms and attitude to carry glucose as a countermeasure to prevent hypoglycemia increased during the study.ConclusionsSitagliptin did not increase the percentage of patients with hypoglycemia among elderly patients with type 2 diabetes mellitus. However, hypoglycemia occurred more frequently in add‐on therapy to sulfonylurea or when the sitagliptin dose was increased in combination therapy, showing that sitagliptin should be used with caution.

Efficacy and safety of sitagliptin in elderly patients with type 2 diabetes mellitus.

The aim of the present study was to assess the efficacy and safety of sitagliptin in elderly patients with type 2 diabetes mellitus. A total of 188 patients were enrolled who had type 2 diabetes mellitus with poor glycemic profiles (hemoglobin A1c [HbA1c] ≥6.2%). Patients were assigned to one of three age groups (<65, 65-74 and ≥75 years) and received 50-100 mg of sitagliptin daily for 12 months. Changes in HbA1c classified by age and body mass index (BMI) were assessed in addition to physiological parameters. Mean HbA1c decreased significantly in all age groups (<65 years 8.01 ± 1.59% to 7.29 ± 1.23%; 65-74 years 7.61 ± 1.11% to 7.05 ± 0.99%; ≥75 years 7.21 ± 0.87% to 6.74 ± 0.96%). Reductions in HbA1c were not significantly different among age groups (P = 0.324). In older patients aged 65-74 years and ≥75 years, HbA1c decreased significantly in lean (BMI <25 kg/m2 ) patients (7.52 ± 1.10% to 6.99 ± 1.08%; P < 0.001) and in obese (BMI ≥25 kg/m2 ) patients (7.25% ± 0.90% to 6.86% ± 0.86%; P = 0.015); the changes in HbA1c were not significantly different between the lean and the obese groups (P = 0.943). Adverse events occurred in 12 patients (10.3%) aged ≥65 years, although there was no significant difference among the three age groups. Sitagliptin treatment offers elderly patients aged ≥65 years efficacious and safe reductions in HbA1c values regardless of BMI. Geriatr Gerontol Int 2018; 18: 631-639.

Erratum to: Efficacy and safety of sitagliptin in elderly patients with type 2 diabetes mellitus and comparison of hypoglycemic action of concomitant medications: a subanalysis of the JAMP study.

[This corrects the article DOI: 10.1007/s13340-017-0330-2.].

Efficacy and safety of sitagliptin in elderly patients with type 2 diabetes mellitus and comparison of hypoglycemic action of concomitant medications: a subanalysis of the JAMP study

To determine the efficacy and safety of sitagliptin when used with some therapeutic drugs to treat elderly patients. Sitagliptin (50mg/day) was added to the pre-existing therapy for type 2 diabetes. Changes in the glycated hemoglobin (HbA1c) level after 3months of treatment were compared with the baseline, and exploratory analysis was performed. These analyses were conducted as subanalyses of the JAMP study, which was an open-label observational study. For patients who were≥65years of age, the change in HbA1c level from baseline ranged from -0.50 to -0.87% at 3months after starting treatment. There was no significant difference in the change in HbA1c level between the patients treated with different concomitant drugs. No significant difference in HbA1c variations at 3 and 12months from baseline was noted among the three age groups (≥75, 65-74, and<65years). Multiple regression analysis was performed, and it revealed that patients with higher HbA1c levels at baseline were likely to show decreased HbA1c levels, while those with higher triglyceride (TG) levels were unlikely to show decreased HbA1c levels. Sitagliptin has the potential to both improve glycemic control and prevent hypoglycemia, and can be considered a potent alternative drug.

Long-term Efficacy and Safety of Sitagliptin in Elderly Patients with Type 2 Diabetes Mellitus.

Objective We herein conducted a retrospective study to evaluate the long-term efficacy and safety of sitagliptin treatment in elderly patients with type 2 diabetes mellitus. Methods We analyzed the changes in glycemic control in 112 Japanese type 2 diabetes patients over 65 years of age treated with 50 mg/day sitagliptin. Hemoglobin A1c (HbA1c) levels, liver and kidney functions, and usage of hypoglycemic agents were recorded for 24 months. Results HbA1c levels were significantly decreased, and the significance of HbA1c reduction was maintained during the observation period [from 7.7±1.1% to 7.2±0.7% (p<0.001) at the end of observational period]. The %change in HbA1c levels was significantly and negatively correlated with the baseline HbA1c levels (r=-0.51, p<0.001), but not with age, duration of diabetes, or the estimated glomerular filtration rate (eGFR). No patient experienced severe hypoglycemia episodes, and aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, and the eGFR remained unchanged. The dose of sulfonylurea was finally decreased in 72% of patients treated with sulfonylurea. Conclusion Sitagliptin treatment continually decreases the HbA1c level for 24 months and is useful to reduce the dose of sulfonylurea in elderly patients with type 2 diabetes.

Two-year assessment of the efficacy and safety of sitagliptin in elderly patients with type 2 diabetes: Post hoc analysis of the ASSET-K study.

BackgroundThere have only been a few reports about use of dipeptidyl peptidase 4 (DPP-4) inhibitors in elderly patients with type 2 diabetes mellitus (T2DM), suggesting that the safety of these agents has not been sufficiently demonstrated. We performed a comparative review of the efficacy and safety of sitagliptin for Japanese patients with T2DM managed in the real-world clinical setting.MethodsAn age-stratified analysis was performed of 831 patients who were treated with sitagliptin for 2 years. Parameters assessed included the hemoglobin A1c (HbA1c), body weight, serum creatinine, and adverse events. HbA1c and the incidence of hypoglycemia were also evaluated in patients treated with sitagliptin and a sulfonylurea (SU), who were divided into three age groups (<65 years, 65–74 years, and ≥75 years).ResultsComparison of glycemic control parameters, laboratory values, and adverse events revealed significant improvement of HbA1c, casual postprandial plasma glucose, and fasting plasma glucose in each age group with no change in body weight. Serum creatinine increased significantly in all age groups. Hypoglycemia only occurred in patients who received combined treatment with an SU and sitagliptin, and there was no age-related difference in its incidence.ConclusionsHbA1c was improved by 2 years of sitagliptin therapy in all three age groups, and age did not seem to influence the incidence of hypoglycemic events. These results confirm the efficacy and safety of sitagliptin in patients ≥ 75 years old, suggesting that it is also useful for treating elderly patients with T2DM.

Sitagliptin for Elderly Patients Aged 75 Years or Older with Inadequately Controlled Type 2 Diabetes with Common Antidiabetes Treatments

Background: The purpose of this study was to evaluate the effects of sitagliptin in elderly patients with type 2 diabetes aged 75 years or older versus those aged 65 - 74 years. Methods: Outpatients aged 65 years or older with type 2 diabetes who received sitagliptin at a dose of 50 mg daily for 6 months were divided into two groups: those who were 75 years and older and those who were 65 - 74 years. The efficacy and safety were retrospectively evaluated by comparison of laboratory values before and after the administration of sitagliptin and by review of adverse events after treatment. Results: One hundred and twelve older patients with type 2 diabetes were studied. Six months after the initiation of sitagliptin, participants’ hemoglobin A1c was significantly decreased by 1.09% ± 0.8% in 65 - 74-year-olds (66 patients; mean age, 69.1 ± 3.0 years; mean HbA1c before administration, 8.4% ± 0.8%) and by 1.05% ± 0.8% in patients 75 years or older (46 patients; mean age, 79.8 ± 4.1 years; mean HbA1c before administration, 8.5% ± 0.7%). There was no significant difference in hemoglobin A1c between the two groups. Furthermore, sitagliptin was well tolerated in both age groups. Conclusions: In elderly patients (75 years or older) with type 2 diabetes, the effect of sitagliptin was similar that in older patients (younger than 75 years) with type 2 diabetes.

Safety of Sitagliptin in Elderly Patients with Type 2 Diabetes: A Pooled Analysis of 25 Clinical Studies

The aim of this study was to evaluate the safety and tolerability of sitagliptin 100 mg/day in elderly patients with type 2 diabetes. A post hoc pooled analysis of 25 randomized, double-blind, parallel group clinical studies with results available as of 1 December 2011. Multicenter, international clinical trials. Patients with type 2 diabetes aged 65 years or older. Patients were randomized to sitagliptin 100 mg/day (n = 1,261) or a comparator (n = 1,185) for 12 weeks to 2 years. In each study, investigators reported serious and non-serious adverse events that occurred during the study, and serious adverse events occurring within 14 days following the last dose of study drug. This analysis used patient-level data from each study to assess the exposure-adjusted incidence rates of specific adverse events that occurred following initiation of study drug. Summary measures of adverse events overall were similar between the sitagliptin and non-exposed (active comparator or placebo) groups, except for higher incidences of deaths and drug-related adverse events in the non-exposed group. Incidence rates of specific adverse events were generally similar between the two groups, with the exception of hypoglycemia. A lower incidence rate of hypoglycemia was observed in the sitagliptin group compared with the non-exposed group [7.0 vs. 14.3 per 100 patient-years; difference -7.6 (95 % CI -11.2 to -4.3]), primarily due to greater use of sulfonylureas in the non-exposed group. In this pooled safety analysis of elderly patients with type 2 diabetes, treatment with sitagliptin 100 mg/day was generally well tolerated for up to 2 years.